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NCT05848349 Clinical Trial

Vitamin D Status Among Infertile Women in Sweden

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Status, Its Determinants and IVF Outcomes Among Infertile Women in South-Western Sweden.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05848349
Other study ID # VitDIVF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date August 30, 2021

Study information
Verified date April 2023
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this prospective cohort study is to learn about the overall and seasonal prevalence of vitamin D insufficiency and its determinants in a population of women with infertility who will go through in vitro fertilization in Sweden. The main questions it aims to answer are: - What is the prevalence of vitamin D insufficiency? - What are the determinants of this insufficiency? Participants will be asked to complete a questionnaire validated for dietary assessment of vitamin D intake and sun exposure habits and they will leave a blood sample for measurement of 25(OH)D concentration. Researchers will compare the in vitro fertilization outcomes between women with vitamin D insufficiency and sufficiency to see if there is any difference.

Recruitment information / eligibility
Status Completed
Enrollment 265
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - women aged 18-38 years, who will go through in vitro fertilization for infertility. Exclusion Criteria: - women who will go through pre-implantation genetic testing - women who will go through sperm- or oocyte donation treatment - Fertility preservation cycles

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Department of Obstetrics and Gynecology, Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of vitamin D insufficiency Overall and seasonal prevalence of vitamin D insufficiency September 2020 - August 2021
Primary Determinants of vitamin D insufficiency Determinants (dietary, sun exposure habits) of vitamin D insufficiency September 2020 - August 2021
Secondary In vitro fertilization outcomes Pregnancy outcomes (biochemical pregnancy, clinical pregnancy, miscarriage, live birth) after in vitro fertilization between women with and without vitamin D insufficiency. September 2020 - August 2021
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